Identification of Gene Polymorphism in Patients With Sick Sinus Syndrome in Chinese Population in Taiwan
1 other identifier
observational
300
1 country
1
Brief Summary
Background: Sinus node dysfunction is a major cause of bradycardia necessitating pacemaker implantation. Evidences of genetic study supported that some genes involved in the pacemaker current or renin-angiotensin system were related to sinus node dysfunction. However, the influence of gene polymorphisms on sinus node dysfunction was not well studied. Methods: A group of 100 patients with documented sinus node dysfunction and 100 age- and sex- matched healthy control patients will be enrolled into this study. Gene polymorphism study includes the angiotensin-I converting enzyme gene, angiotensin II type 1 receptor gene, HCN1-4, SCN5A, KCNE and other possible gene polymorphisms which are related to sinus node function based on previous reports. Genetic polymorphisms are identified with polymerase chain reaction-based restriction analysis. Comparison of multiple haplotype analysis and single-locus analysis will be analyzed between the cases and controls. Estimated Results: Some genetic polymorphisms of these genes which are related to sinus node function or rennin-angiotensin system will show association with sinus node dysfunction. In multilocus haplotype analysis, some genetic haplotype profiles may demonstrate significant difference between cases and controls. In single locus analysis, some genetic polymorphisms may be associated with sinus node dysfunction. Estimated Conclusion and Clinical Implication: This study will demonstrate the genetic polymorphisms in RAS genes or some other genes associated with sinus node dysfunction. These results will support the roles of these genetic polymorphisms in determining the risk of sinus node dysfunction among the Chinese population in Taiwan.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2006
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 12, 2006
CompletedFirst Posted
Study publicly available on registry
April 13, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedApril 13, 2006
April 1, 2006
April 12, 2006
April 12, 2006
Conditions
Eligibility Criteria
You may qualify if:
- Heart rate was less than 40/min or long pause more than 3 seconds in series EKG or 24-hour EKG.
- Sinus nodal recovery time exceeds 1600 ms in cardiac electrophysiology study.
You may not qualify if:
- Severe systemic disease.
- Acute coronary syndrome.
- Bradycardia with reversible cause.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China Medical University Hospital
Taichung, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan-Yow Chen, MD
China Medical University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 12, 2006
First Posted
April 13, 2006
Study Start
February 1, 2006
Study Completion
December 1, 2006
Last Updated
April 13, 2006
Record last verified: 2006-04